Disposable needle guide system

ABSTRACT

A needle guide system for a medical imaging instrument comprises a needle guide assembly ( 1, 2 ) and a mounting assembly ( 3, 4 , optionally  5 ) for attaching the needle guide assembly to a transducer, the mounting assembly comprising self-destroying means effective on dismounting. The mounting assembly comprises an attaching clip (4) mountable on a transducer directly or via an adapter ( 5 ), and a locking clip ( 3 ) mountable on the attaching clip from which it can be dismounted easily only by breaking indications of fracture comprised by the attaching clip. The needle guide assembly ( 1, 2 ) comprises a revolver ( 1 ) capable of receiving needles of varying diameter and a journal clip ( 2 ) by which it is mounted on the locking clip ( 3 ).

FIELD OF THE INVENTION

[0001] The present invention relates to a disposable needle guide systemfor a medical imaging instrument, in particular an ultrasonictransducer, for guiding a needle into a selected location of a patientrelative to the imaging instrument, for use in percutaneousinterventional procedures, such as fine needle aspiration, core biopsy,amniocentesis, and drainage.

BACKGROUND OF THE INVENTION

[0002] A great number of needle guide systems for use with ultrasonictransducers and the like are known in the art. Most of them are confinedto be used with a transducer of particular geometry which is aconsiderable drawback in consideration of the considerable number ofultrasonic transducers of differing geometry on the market.

[0003] Another problem with most known needle guide systems is that theyaccept only one diameter size of needle, and that, therefore, their usewith needles of different size necessitates the change of one or severalparts. Present systems also suffer from the drawback that the user hasto assemble the system from a number of parts. In addition most knownneedle guide systems require some sort of adapter which may constitute asubstantial investment on its own. Also, such adapters may be lost ormislaid between individual percutaneous interventions.

[0004] A further problem with many known needle guide systems is thatthey are not truly disposable, that is, they are not easy and cheap tomanufacture and, therefore, tend to be re-used, even if not suited ordesigned to be repeatedly used. They thus may constitute a risk topatients when being re-used improperly.

[0005] The present invention seeks to avoid the aforementioned problems.

OBJECTS OF THE INVENTION

[0006] It is an object of the present invention to provide a needleguide system of the aforementioned kind which can be adapted totransducers of varying shape, in particular ultrasound transducers.

[0007] It is another object of the present invention to provide a needleguide system of the aforementioned kind which has improved flexibilityand functionality in comparison with needle guide systems presently inuse.

[0008] It is an additional object of the invention to provide a needleguide system accepting needles of varying diameter without the need forexchanging parts.

[0009] It is a further object of the invention to provide a needle guidesystem which enables the user to choose between an adapter-basedsolution and a solution where a disposable device is directly fit to thetransducer.

[0010] It is a particularly important object of the invention to providea truly disposable needle guide system, that is, a system which cannotbe re-used at all or with considerably difficulty only.

[0011] Further objects of the invention are evident from the followingshort description of the invention, the attached drawings illustrating apreferred embodiment, the detailed description thereof, and the appendedclaims.

SUMMARY OF THE INVENTION

[0012] According to the present invention is provided a needle guidesystem of the aforementioned kind, comprising a needle guide assemblyand a mounting assembly for attaching the needle guide assembly to atransducer, the mounting assembly comprising self-destroying meanseffective on dismounting.

[0013] It is preferred for the needle guide assembly to comprise needleguide means accepting needles of different diameters, in particularneedles from three to six different diameters.

[0014] It is also preferred for the needle guide means to comprise arevolver mounted in a stepwise lockable revolving manner on a journalclip.

[0015] The journal clip is mountable on the mounting assembly. Accordingto the invention it is possible to provide a journal clip which can bemounted in two or more angular or height positions in respect of themounting assembly.

[0016] According to a preferred aspect of the invention, the mountingassembly comprises an adapter mountable on a transducer, an attachingclip mountable on the adapter and a locking clip mountable on theattaching clip. It should be understood that the attaching clip isinterposed between the adapter and the locking element on which theneedle guide assembly is mountable.

[0017] It is however also possible for the attaching clip to be directlymountable the transducer; the portion of the transducer at which theattaching clip is mountable should be designed in a manner functionallycorresponding to the mounting portion of the adapter. In such case noseparate adapter will be needed. The variant of the needle guideassembly in which mounting portion of the adapter is comprised by thetransducer is fully encompassed within the present invention.

[0018] It is preferred for the adapter to be of a generally abutableshape in respect of the transducer to which it is intended to be mountedin a transducer encircling position. The adapter preferably has two freeends provided with a cooperating snap connection which is closed onmounting and which is preferably not easily dismountable by hand.

[0019] According to a preferred second aspect of the invention theattaching clip comprises a base and first and second pairs of prehensileorgans extending from the short or lateral ends of the base (or frompositions close to the short ends) in opposite directions. A roughapproximation of the general shape of a preferred attaching clip of theinvention are two letters C joined back-to-back but not necessarily ofthe same size. The first pair of prehensile organs, such as claws, isdesigned in a manner to enable it to grip a U-formed portion of theadapter mounted on a transducer (or to directly grip a portion of thetransducer of corresponding design) and to snap into position by itsterminal portions interlocking with recesses provided in correspondingexternal faces of the adapter. Preferably further means for firmlyattaching the adapter to the attaching clip are provided at facing facesof the attaching clip and the adapter, such as a transverse ridgedisposed on an external face of the adapter insertable into a facingtransverse recess disposed in the attaching clip.

[0020] According to a preferred aspect of the invention the claws of thesecond prehensile organ are adapted to grip opposite sides of thelocking clip in a way so as to hold it against the attaching clip andlocking it in this position. Once snapped into position the lockingelement is not easily removed by hand from the attaching clip.

[0021] The locking element preferably comprises a front and back supportareas, such as support faces, grids or similar, tilting in respect toeach other, the back face facing the attaching clip whereas the frontface faces the needle is preferably selectable to fit a particular typeof transducer or needle insertion depth.

[0022] The needle assembly is mountable on the mounting assembly byattaching the journal clip to the locking element. Preferably thejournal clip is mounted in a manner making it difficult or impossible toremove it from the locking element in a mounted position, for instanceby snap tongues inserted into through openings in the locking elementinto which they lock and/or by snap tongues which can grip edges of thelocking element.

[0023] It is preferred for the needle guide system of the invention tobe easily detachable from a position mounted on a transducer only bydamaging (breaking) a weak point, such as a fracture zone or line, ofthe mounting assembly. Particularly preferred is for such a weak point,kerf or facture zone to be comprised by the second prehensile means, inparticular by one claw thereof.

[0024] It is preferred for the attaching clip to comprise breaking meansfor such destructive dismounting, the breaking means comprising atwisting element and a fracture zone or line. It is preferred for thefracture zone or line to be easily broken by displacement of sectionsadjacent to the zone or line in the direction of the transducer axis.Particularly preferred is the removal of a support for one or bothsecond prehensile means providing for release of the locking element. Bymaking the dismounting of the attaching clip conditional on itsdestruction the unsafe re-use of the needle assembly is prevented.

[0025] It is preferred for the revolver to comprise a multitude ofneedle receiving slots, for instance, three to six slots, each slotbeing dimensioned to receive a needle of different diameter. Therevolver has about cylindrical shape with the slots disposed in itsmantle in parallel with the cylinder axis and in an about equidistantmanner along its circumference corresponding to an exactly equidistantmanner in regard of the axes of their respective needles. Whereas thewidth of each slot corresponds closely to the diameter of the needlewhich it is intended to receive, its depth is slightly less than saiddiameter. Thereby the needle protrudes somewhat in a radial directionfrom the slot.

[0026] It is furthermore preferred for the revolver to comprise amultitude of locking elements. The locking elements, for instance,radially extending locking ribs, are arranged for locking the revolverin a position in which the a needle disposed in the slot ofcorresponding diameter is made abut a recess in a wall of the angularclip facing away from the transducer. Thereby the displacement of theneedle is restricted to be strictly axial.

[0027] According to the present invention is also provided a disposableneedle guide system comprising a needle guide assembly and a mountingassembly mountable on a transducer, the mounting assembly comprising anattaching clip mountable on a mounting portion of the transducer or onan adapter mountable on the transducer, and a locking clip mountable onthe attaching clip so as to be releaseably held at its opposite ends byholding portions of the attaching clip, the release means including akerf or other indication of fracture comprised by a support portion ofthe attaching clip supporting one of said holding portions and beingeasily breakable by hand. It is preferred for the release function tocomprise a handle which can be turned to break the kerf or otherindication of fracture and thereby irreversibly release the lockingclip.

[0028] If not indicated otherwise, in this specification the orientationof the various elements of the needle guide system of the invention isin relation to the transducer. Ultrasound and other transducers arenormally of a cylindrical, rectangular, parallelepipedeal or similarconfiguration for which a longitudinal axis can be defined. Directionsperpendicular to that axis are termed “transverse” or “lateral”. Facesfacing the transducer are termed “interior” or “inwardly facing” orsimilar. Faces facing away from the transducer are termed “exterior” or“outwardly facing” or similar.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In the following the invention will be explained in greaterdetail by reference to preferred embodiments illustrated in a rawdrawing showing in

[0030]FIG. 1 a first embodiment of the needle guide system according tothe invention mounted on an ultrasonic transducer, in a perspective viewand with the transducer not shown;

[0031]FIG. 2 the embodiment of FIG. 1, in an exploded view;

[0032]FIGS. 3a-ethe individual elements of the embodiment of FIG. 1, insubstantially the same view as in FIG. 1;

[0033]FIG. 4 the adapter of the embodiment of FIG. 1 in an unmountedstate, in a bottom view;

[0034]FIG. 5 the embodiment of FIG. 1 with the transducer shown and ahypodermic needle mounted, in a bottom view;

[0035]FIG. 6 a second embodiment of the needle guide system according tothe invention, in the same view as in FIG. 5.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0036] The first embodiment of the needle guide system of the inventionshown in FIGS. 1-5 comprises five elements: a revolver 1, an journalclip 2, a locking clip 3, an attaching clip 4, and an adapter 5. Theelements 1-5 are preferably made of suitable polymer material(s).

[0037] The revolver 1 is mounted rotatably between lower 14 and upper 15arms of the journal clip 2 extending from a base plate 13 and carryingbearing necks 17 and 18, respectively, which extend into a central bore6 of the revolver at its respective ends. Juts 7 are disposed in thebore 6 close to its lower and upper end for snapping interaction withcatches 19 on the bearing necks 17, 18. Five such catches 19 aresymmetrically arranged on each bearing neck 17; 18 allowing the revolver1 to be displaced between five fixed positions by hand. These fixedpositions correspond to five axial slots 8-12 on the revolver 1, eachslot being dimensioned to receive a hypodermic needle 70 of certainwidth. Thereby the needle guide of the invention can be used withneedles of various (standard) dimensions. For mounting the needle 70 isplaced in the slot 10 of corresponding width, and the revolver 1 withthe needle 70 in the slot 10 is rotated until the needle 70 is locked inthe slot 10 by the abutting the base plate 13 at a shallow indentation(not shown). The locking mechanism uses the resilient nature of thepolymer materials of the revolver 1 and the journal clip 2; it does notprevent the needle from being moved in the direction of the slot 10. Thejournal clip 2 comprises a stiffening rib 16. It is useful to providethe journal clip 2 and the elements 3 and 4 with further stabilizingstructures like the stiffening rib 16 but is not shown in the drawingfor the sake of clarity. How the journal clip 2 with the revolver 1 ismounted on the remainder of the needle guide system by of upper 20, 21and lower 24 claws extending from the rear side of the base plate 13(the side facing away from the revolver 1) will be explained later.

[0038] The needle guide assembly of the invention can be mounted ontransducers of different geometry by an adapter 5 designed to fit theindividual transducer. It is also possible to incorporate the portion ofthe adapter at which the remainder of the needle guide assembly is to bemounted in the transducer; in such case a separate adapter becomessuperfluous. Only one external wall (a wall facing away from thetransducer) of the adapter 5 (or the transducer, if no separate adapteris being used) need to be designed in a standard manner so as receivethe remaining needle guide system elements 1-4.

[0039] This wall is the facing wall of the base plate 51 in FIG. 3e. Thebase plate 51 forms part of a belt structure comprising left 52 andright 53 arms provided with angular end portions 64, 63 and joined tothe base plate 51 by right 56 and left 57 thin flexible hinge sections.On mounting the base plate 51 on a transducer 71 its internal wall ispressed against the corresponding transducer wall, the arms 52, 53 arefolded towards each other so as to enclose the transducer 71, and theadapter 5 is secured at the transducer 71 by a snap connection 65, 66,67 disposed at the external walls of it angular end portions 63, 64comprising a tongue 65 with a head 66 integral with the right endportion 63 insertable into a catch 67 integral with the left end portion64. The snap connection 65, 66, 67 is of a self-locking sort that is noteasily disassembled by hand.

[0040] The journal clip 2 with the revolver 1 is attached to and lockedon the adapter 5 by means of an attaching clip and a locking clip.

[0041] The attaching clip 4 comprises a base plate separated into right36 and left 38 sections by a thin-walled flexible bridge 40 which has ahinge function. To the right section 36 is joined a claw 37 at a rightangle provided with an inwardly extending claw head 49. To the leftsection 38 is joined a left claw 39 at a right angle provided with aninwardly extending claw head 48.

[0042] The attaching clip 4 is placed with its left right base platesection 38 against the external face of the adapter base plate 51 so asto make a retainer key 72 disposed at the interior face of left section36 fit into a recess 55 disposed on the exterior face of the adapterbase plate and the right claw head 49 fit into a recess 54 disposed atthe external face of the right arm 53 of the adapter 5. Then the leftsection 38 is swiveled around the flexible bridge 40 which forms a sortof hinge until it abuts the adapter base plate 51; thereby the rightclaw head 48 is inserted in recess (not shown) disposed on the externalface of the adapter left arm 52 corresponding to recess 54. In FIGS. 2-4the attaching clip 4 is shown in a state prior to it being clamped onadapter 5.

[0043] The attaching clip 4 is locked on the adapter 5 by means of thelocking clip 3 which comprises two faces, an outwardly facing first faceidentical with the exterior face of a base plate 25 and an inwardlyfacing second face defined by the internal face of a right lockingflange 30 provided with a locking cylinder 31 and the internal face of atransverse stiffening rib 34 as well as the internal faces of verticalstiffening ribs (not shown) extending downwards from rib 34. The firstface is tilted in respect of the second face by an angle of about 15°.The internal face of the locking clip comprises a recess (not shown)which is engageable with a retainer key 47 disposed at the external faceof the right base element section 36.

[0044] For locking the locking 3 on the attaching clip 4 the former isprovided with laterally extending left 28 and right 30 locking arms, theright locking arm comprising a cylindrical end portion 31 from whichupper 32 and lower 46 projections extend and the left locking armcomprising a handle 29. The left and right locking arms 28, 30 areinsertable into the gaps 68, 69 of left 41 and right 45 locking clipholders arranged on the external faces of the left 38 and right 36attaching clip base plate sections. The left locking clip holdercomprises clamping flanges 42, 43 and a rear support portion 44. Incombination with the cylindrical end portion 31 of the right locking arm30 the right locking clip holder 45 provides a slight hinge functionused on mounting: the cylinder portion 31 of locking clip 3 is firstinserted into gap 69 of the right locking clip holder 45; then the leftside of locking clip 3 is flipped towards clamp flange 42 of the leftlocking clip holder 41 to make it snap into its gap 68 from whichposition it is not easily dismounted by hand. The locking clip 3furthermore is locked in this position by a retainer key 47 disposed onthe external face of the right section 36 of the attaching clip baseplate engaging with a grove and rib indentations (not shown) disposed onthe internal face of the locking clip 3.

[0045] The journal clip 2 with the revolver 1 is mounted on the lockingclip by inserting a pair of lower claws 24 (only one shown) disposed onthe interior face of base plate 13 of the journal clip 2 into claw ducts26, 27 penetrating the locking clip base plate 25, the claws beingretained in the ducts 26, 27 by keyways (not shown) engaging with thebase plate. Simultaneously a pair of upper claws 20, 21 disposed on theinterior face of base plate 13 of the journal clip 2 above said lowerclaws 24 are pushed over the top face 73 of the locking clip base plate25 with which they engage by keyways 22, 23 in two selectable positionsproviding for different angles of hypodermic needle orientation. Therebythe journal clip 2 is locked on the locking clip 3 in a irreversiblemanner since the snap connection provided by claws 20, 21, 24 is noteasily dismounted by hand.

[0046] The various snap connections make use of the resiliency ofselected polymer materials.

[0047] As already pointed out the various snap connections incombination with the design of the needle guide system according to theinvention provide for the mounted system not being easily dismountablein its integrity, thus preventing unautorized multiple use which mightput the patient at risk.

[0048] The needle guide system according to the invention can be easilydismounted only by damaging an important component, the attaching clip.To this effect, the attaching clip is provided with an arrangementsupporting the left locking clip holder 41 which is attached to the leftbase plate section 38 by a rather thin bridge 58 of material which issufficiently stable to provide support (in a mounted position) indirection perpendicular to the base plate and parallel with grove (gap)68 but not in a transverse direction indicated by arrow A in FIG. 4. Inthat transverse direction the clip holder 41 is supported by a releasegrip 50 via supports 59 and, to a lesser degree, 60. The clip holder 50is attached to the external face of the left claw 39 by a hinge pin 62and a further support 61. The supports 59, 60, 61 are designed to beeasily broken by relative displacement of the elements which theyconnect in a perpendicular direction. This capability is used whenreleasing the left locking clip holder 41 by turning the release griparound the hinge pin 62. The hinge pin 62 is not and need not be a pinfreely rotatable in a bearing or hinge, it is sufficient that thematerial constituting it allows the clip holder 50 to be rotated by handwhile being sufficiently rigid to hold the clip holder 50 in positionagainst the pressure exerted by the mounted locking clip 3 in normaluse. The breaking of supports 59, 60 on rotating clip holder 50 out ofits plane allows the left locking clip holder 41 to flip away from thelocking clip 3 in the direction of arrow A, thus allowing the lockingclip 3 with the journal clip 2 and the revolver 1 to be removed. Therebythe attaching clip 4 can be folded away from the adapter 5 (in thedirection of arrow B) and removed. The pressure exerted on the adapter 5by claws 37, 39 thus comes to an end which facilitates its dismounting.

[0049] The second embodiment of the needle guide system of the inventionshown in FIG. 6 comprises four elements: a revolver 1, an journal clip2, a locking clip 3, and an attaching clip 4. The four elements 1, 2, 3,4 of the second embodiment fully correspond to elements 1, 2, 3, 4 ofthe first embodiment and are therefore identified by same referencenumbers. In the second embodiment the mounting portion of the adapter 5of the first embodiment is incorporated in the transducer 80 on whichthe attaching clip 4 is directly mounted.

1. A needle guide system for a medical imaging instrument, in particularan ultrasonic transducer, for guiding a needle into a selected locationof a patient relative to the imaging instrument, for use in percutaneousinterventional procedures, such as fine needle aspiration, core biopsy,amniocentesis, and drainage, comprising a needle guide assembly and amounting assembly for attaching the needle guide assembly to atransducer, the mounting assembly comprising self-destroying meanseffective on dismounting.
 2. The needle guide system of claim 1,comprising needle guide means accepting needles of different diameter.3. The needle guide system of claim 2, wherein the needle guide meanscomprise a revolver mounted in a stepwise lockable revolving manner on ajournal clip.
 4. The needle guide system of claim 3, wherein the journalclip is mountable on the mounting assembly.
 5. The needle guide systemof claim 4, where the journal clip is mountable in two or more angularor height positions in respect of the mounting assembly.
 6. The needleguide system of claim 1, wherein the mounting assembly comprises anadapter mountable on a transducer, an attaching clip mountable on theadapter and a locking clip mountable on the attaching clip.
 7. Theneedle guide system of claim 1, wherein the mounting assembly comprisesan attaching clip mountable on the transducer and a locking clipmountable on the attaching clip.
 8. The needle guide system of claim 6,wherein the adapter is of a generally abutable shape in respect of thetransducer to which it is intended to be mounted in a transducerencircling position.
 9. The needle guide of claim 6, wherein the adapterhas two free ends provided with a cooperating snap connection which isclosed on mounting and which is not easily dismountable by hand.
 10. Theneedle guide system of claim 6, wherein the attaching clip comprises abase and first and second prehensile organs such as pairs of clawsextending in opposite directions from the short or lateral ends of thebase or from positions close to the short ends.
 11. The needle guidesystem of claim 7, wherein the attaching clip comprises a base and firstand second prehensile organs such as pairs of claws extending inopposite directions from the short or lateral ends of the base or frompositions close to the short ends.
 12. The needle guide system of claim10, wherein the first prehensile organ is designed for gripping aU-formed portion of the adapter mounted on a transducer.
 13. The needleguide system of claim 11, wherein the first prehensile organ is designedfor gripping a portion of the transducer.
 14. The needle guide system ofclaim 10 or 12, wherein the second prehensile organ is designed forgripping opposite sides of the locking clip so as to hold the lockingclip against the attaching clip and locking it in this position.
 15. Theneedle guide system of claim 11 or 13, wherein the second prehensileorgan is designed for gripping opposite sides of the locking clip so asto hold the locking clip against the attaching clip and locking it inthis position.
 16. The needle guide system of claim 6, wherein theneedle guide assembly is mountable on the mounting assembly by attachingthe journal clip to the locking element.
 17. The needle guide system ofclaim 7, wherein the needle guide assembly is mountable on the mountingassembly by attaching the journal clip to the locking element.
 18. Theneedle guide system of claim 16, wherein the journal clip is mounted ina manner making it difficult or impossible to remove it from the lockingelement.
 19. The needle guide system of claim 17, wherein the journalclip is mounted in a manner making it difficult or impossible to removeit from the locking element.
 20. The needle guide system of claim 1,designed to be detachable from a position mounted on a transducer onlyby breaking a kerf or a fracture zone or line of the mounting assembly.21. The needle guide system of claim 20, wherein the kerf or facturezone or line is comprised by the second prehensile means.
 22. Adisposable needle guide system comprising a needle guide assembly and amounting assembly mountable on a transducer, the mounting assemblycomprising an attaching clip mountable on a mounting portion of thetransducer or on an adapter mountable on the transducer, and a lockingclip mountable on the attaching clip so as to be releaseably held at itsopposite ends by holding portions of the attaching clip, the releasemeans including a kerf or other indication of fracture comprised by asupport portion of the attaching clip supporting one of said holdingportions and being easily breakable by hand.